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Transport PLUS Intervention

Primary Purpose

Fall, Accidental, Fall, Hospital Readmission

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transport PLUS group
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fall, Accidental focused on measuring falls, readmissions, emergency department visits, transitions of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Emergency Medical Technicians (EMTs) are eligible to participate in study if

  • employed by Hunter EMS
  • over the age of 18 years, and
  • certified as an EMT in New York State.

Patient participants are eligible if

  • over the age of 65 years
  • being discharged from the study hospital, and
  • being transported directly to home.

Exclusion Criteria:

  • EMTs who expect to leave the job in less than 1 year
  • EMTs who have been previously trained in Transport PLUS.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transport PLUS group

Routine Care

Arm Description

EMTs randomized to the Transport Plus group will view a 60-minute training video and then complete a 60-minute simulation training exercise on how to conduct the home fall hazard assessment (FHA) and the discharge comprehension assessment (DCA) and how to complete the FHA and DCA checklists. The FHA involves performing a visual assessment of the home environment and noting certain fall hazards. The DCA involves engaging the patient or caregiver in a conversation to assess their level of understanding of the elements of the discharge instructions. The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence

Providers randomized to routine care will not be trained on the FHA or DCA or the completion of the checklists. All EMTs in both groups (Transport Plus and standard education), will be asked to answer some demographic questions and will be trained to collect responses to 3questions commonly used to assess a patient's risk of falling and to collect best contact information for phone follow up from patients or their caregivers and to obtain permission for a follow-up phone call from research personnel.

Outcomes

Primary Outcome Measures

Rate of falls
Rate of falls following transport home by ambulance
Rate of return ED visits
Rate of return ED visits following transport home by ambulance

Secondary Outcome Measures

Rate of falls
Rate of return ED visits
Numbers of patients with ED visits within 3 days of participation in study intervention or control arm.
Readmission
Numbers of patients with readmissions after study intervention

Full Information

First Posted
February 6, 2017
Last Updated
January 30, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03046771
Brief Title
Transport PLUS Intervention
Official Title
Randomized Controlled Trial Evaluating Efficacy of EMS Providers Performing Discharge Comprehension and Home Fall Hazard Assessments
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis: 'Transport PLUS,' a low cost, easily generalizable intervention performed by Emergency Medical Technicians while transporting a patient home from the hospital, can improve transitions of care and improve patient safety following hospitalization as measured by decreased rates of falls and reduced rates of return to the hospital.
Detailed Description
The moment of transition between the hospital and the home is susceptible to lapses in quality and loss of key information regarding a patient's care. An increasing amount of attention is being given to improving the transition of care by targeting factors that contribute to return Emergency Department (ED) visits and readmissions. Following a hospitalization, as many as 40% of patients over age 60 will experience a fall in the subsequent six months and 76% of older adult patients are uncertain about their follow-up care plan. Patients transported home by ambulance following an ED visit were found to have a significantly higher rate of return ED visits at 30 days then overall rates for older adult ED patients (27.8% vs. 11.5%). In response to these challenges, the researcher's study group developed and piloted an innovative care model known as "Transport PLUS" in which specially trained emergency medical technicians (EMTs) who are already transporting an older adult (65+ years in age) patient home from the ED add to their service two simple interventions - a home fall hazard assessment (FHA) and a discharge comprehension assessment (DCA). Both interventions are facilitated and measured using a checklist developed through a systematic review of the literature and existing tools, and later refined through EMT and patient focus groups. This study will test the hypothesis that 'Transport PLUS,' a low cost, easily generalizable intervention, can improve transitions of care and improve patient safety following hospitalization as measured by decreased rates of falls and reduced rates of return to the hospital. The researchers will conduct a pilot cluster randomized controlled trial comparing the Transport PLUS intervention to standard care in a population of older adult patients being discharged from the hospital. The researchers will randomize EMS providers to either perform Transport PLUS (the intervention) or to provide routine transport. It is estimated that approximately 400 patients over age 65 will be transported home from the study hospital by participating providers during the study enrollment period. Patient participants will receive Transport PLUS (n=200) or routine care (n=200) as determined by the transporting provider. Primary outcomes will be the rate of falls in the 3 months following hospitalization and 3-day and 30-day return ED visits (with or without a hospitalization). Process measures will include removal of fall hazards at 3 months and compliance with discharge instructions. Extending beyond the grant period, the researchers intend to follow the cohort for up to 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Accidental, Fall, Hospital Readmission, Emergency Medical Services
Keywords
falls, readmissions, emergency department visits, transitions of care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transport PLUS group
Arm Type
Experimental
Arm Description
EMTs randomized to the Transport Plus group will view a 60-minute training video and then complete a 60-minute simulation training exercise on how to conduct the home fall hazard assessment (FHA) and the discharge comprehension assessment (DCA) and how to complete the FHA and DCA checklists. The FHA involves performing a visual assessment of the home environment and noting certain fall hazards. The DCA involves engaging the patient or caregiver in a conversation to assess their level of understanding of the elements of the discharge instructions. The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Providers randomized to routine care will not be trained on the FHA or DCA or the completion of the checklists. All EMTs in both groups (Transport Plus and standard education), will be asked to answer some demographic questions and will be trained to collect responses to 3questions commonly used to assess a patient's risk of falling and to collect best contact information for phone follow up from patients or their caregivers and to obtain permission for a follow-up phone call from research personnel.
Intervention Type
Behavioral
Intervention Name(s)
Transport PLUS group
Intervention Description
The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence.
Primary Outcome Measure Information:
Title
Rate of falls
Description
Rate of falls following transport home by ambulance
Time Frame
up to 3 months
Title
Rate of return ED visits
Description
Rate of return ED visits following transport home by ambulance
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of falls
Time Frame
up to 12 months
Title
Rate of return ED visits
Description
Numbers of patients with ED visits within 3 days of participation in study intervention or control arm.
Time Frame
3 days
Title
Readmission
Description
Numbers of patients with readmissions after study intervention
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Emergency Medical Technicians (EMTs) are eligible to participate in study if employed by Hunter EMS over the age of 18 years, and certified as an EMT in New York State. Patient participants are eligible if over the age of 65 years being discharged from the study hospital, and being transported directly to home. Exclusion Criteria: EMTs who expect to leave the job in less than 1 year EMTs who have been previously trained in Transport PLUS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G Munjal, MD,MPH,MSCR
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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